Home Medical Product Division

Medical Product Division

Background

The Medical Product Division (MPD) is primarily mandated to regulate medical products both modern and traditional including medical devices, health supplements and blood and blood products as per the provisions under the Medicines Act of Kingdom of Bhutan 2003. The Division aims towards promoting consumers’ confidence through ensuring quality, safety and efficacy/effectiveness of the medical products with the ultimate goal of protecting and advancing public health. The MPD regulates human allopathic medicines, vaccines, veterinary medicines, blood and blood products, traditional medicines, supplements and medical devices. Product registration and post marketing surveillance including testing of medical products and inspection of sale, storage and manufacturing premises form the core mandate of the authority and its primary objective is to increase patient’s access to quality assured medicinal products.

Who is Who

Name Designation Email ID
Mr. Jigme Tenzin Chief Regulatory Officer jtenzin@bfda.gov.bt
Mr. Sangpo Program Analyst sangpo@bfda.gov.bt
Mr. Jigme Dorji Sr. Regulatory Officer jdorji@bfda.gov.bt
Ms. Kinley Penjor Tshomo Sr. Regulatory Officer kptshomo@bfda.gov.bt
Ms. Gyelwas Kuenzom Sr. Regulatory Officer gkuenzom@bfda.gov.bt
Mr. Sonam Chophel Sr. Regulatory Officer schophel@bfda.gov.bt
Ms. Sangay Choden Regulatory Officer schoden@bfda.gov.bt
Mr. Dorji Regulatory Officer dorji@bfda.gov.bt
Mr. Ugyen Chophel Regulatory Officer uchophel@bfda.gov.bt
Mr. Tashi Lepcha Regulatory Officer tlepcha@bfda.gov.bt
Ms. Tenzin Wangmo Regulatory Officer twangmo@bfda.gov.bt
Ms. Sarim Tshering Assistant Regulatory Officer stshering@bfda.gov.bt
Mr. Loden Jamtsho Assistant Regulatory Officer ljamtsho@bfda.gov.bt
Mr. Guru Assistant Regulatory Officer guru@bfda.gov.bt
Mr. Ugyen Tshering Assistant Regulatory Officer ugyentshering@bfda.gov.bt
Mr. Sonam Jamtsho Assistant Regulatory Office sjamtsho@bfda.gov.bt

Mandates

“To ensure quality, safety and efficacy of medicinal products, the MPD, BFDA is mandated by the Medicines Act of Kingdom of Bhutan and the regulations there-under to enforce the following mandates: “
  1. Authorize the manufacture, import, export, sale, distribution and storage of the medical products including blood and blood products, and medical devices;
  2. Register medical products which are manufactured within as well as imported into the country;
  3. List Health Supplements;
  4. Monitor the competency and skills of personnel involved in manufacture, import and storage sale the medical products;
  5. Inspect premises involved in manufacture, sale, distribution and storage of medical products including blood and blood products, and medical devices;
  6. Conduct lot release of vaccines;
  7. Maintain Up-to-date information in the form of Bhutan National Formulary and Drug Safety information;
  8. Monitor the trends and cases of adverse effects resulting from medical products;
  9. Inform the public on the use and harmful effects of medical products;
  10. Regulate advertisement of medical products;
  11. Promote policies for improved access cost-effective quality medical products;
  12. Conduct research on pertinent issues related to medical products; and
  13. Deliver the regulatory services to the public in a cost effective and efficient manner.

Services

  1. Log on to Government to Citizen (G2C) portal 
  2. After logging in, click on the “Registration of Competent Person” from the list of services.
  3. Enter your Personal details and click next.
  4. Enter the location and business details. Click “Next”.
  5. Upload the required documents and click “Submit”. 
  6. The authority will reach out to you for payment of the application fee.
  7. The date of competency examination will be published on the BFDA website and social media.
  8. Sit for competency examination. 
  9. The Authority will send your competency assessment result via your email address.
  10. You can view and download your Competency Person certificate from “Profile” in the Government to Citizen (G2C) Portal.
  1. Log on to Government to Citizen (G2C) portal 
  2. After logging in, click on the “Renewal of Competent Person” from the list of services.
  3. Enter your Competent Person registration number.
  4. The auto generated details will fetch and upload the required documents. 
  5. Submit the application after all the documents are uploaded.
  1. Log on to Government to Citizen (G2C) portal 
  2. After logging in, click on the “Application for Technical Authorization” from the list of services.
  3. Under the purpose, select “To Sell or distribute medical products” from the drop-down and enter the Competent Persona and Proprietor details. 
  4. Click on “next” after entering all the required details.
  5. Then enter the details on the business and provide the “Self Site Inspection Details” using the checklist provided.
  6. Check the “Declaration” box and click the “next” button.
  7. Upload the required documents and click on the “Submit” button.
  1. Log on to Government to Citizen (G2C) portal 
  2. After logging in, click on the “Renewal of Competent Person” from the list of services.
  3. Enter your TA certificate No and press enter..
  4. The auto generated details will fetch and enter the date of 1st TA Registration date. Click on the “Submit” button. 
  1. Submit the duly filled Application to setup manufacturing plant for medicinal products along with other relevant documents as per Guidance document on Technical Authorization for manufacture and regulatory certification via email to mpd@bfda.gov.bt.    
  2. The concerned official will contact you for any subsequent clarifications.
  1. Submit the duly filled Application for Technical Authorization for Manufacture of Medicinal Products along with other relevant documents as per Guidance document on Technical Authorization for manufacture and regulatory certification via email to mpd@bfda.gov.bt.  
  2. The concerned official will contact you for any subsequent clarifications.
  1. Submit the duly filled Application for GMP Certificate via email to mpd@bfda.gov.bt.
  2. The concerned official will plan for the site audit of the manufacturing plants and accordingly issue cGMP certificate after fulfilment of all the requirements as per  Guidance document on Technical Authorization for manufacture and regulatory certification.
  3. The cGMP certificate will be issued via email to the applicant.

Issuance of Marketing Authorization of Pharmaceutical Products:

  1. Submit the application along with other documents via following links:
    1. Full dossier applications:
      1. Submit the duly filled application for Full registration of medicinal products along with the relevant documents as per Guideline for registration of medicinal products 2020 in ACTD format prescribed by the authority via Full dossier submission link.
    2. ER dossier applications:
      1. Submit the duly filled Application form for expedited registration of medicinal products along with the relevant documents as per Guideline for registration of medicinal products 2020 via ER dossier submission link.
    3. AR dossier applications:
      1. Submit the duly filled Application for Abridge registration of medicinal products along with the relevant documents as per Guideline for registration of medicinal products 2020 via AR dossier submission link.
    4. CR dossier applications:
      1. Submit the duly filled Application for registration of medicinal products via Company recognition along with the relevant documents as per Addendum 2021: Guideline for registration of medicinal products 2020 via CR dossier submission link.
  2. The Authority will check for the format of the dossier submitted and communicate to the client for submission of product samples and payment of application fees if the dossier is as per the format via registered email address.
  3. The dossier submitted will be evaluated by the relevant sections during the monthly Dossier Evaluation Plan.
  4. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  5. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via Missing document submission form.
  6. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of Marketing Authorization of Medical Devices:

  1. Submit the application along with other documents via following links:
    1. Full dossier applications:
      1. Submit the duly filled Application for Full registration of medical devices along with the relevant documents as per Guideline for registration of medical devices 2022 in ACTD format prescribed by the authority via Full dossier submission form for Medical device.
    2. Abridge dossier applications:
      1. Submit the duly filled Application for Abridge registration of medical devices along with the relevant documents as per Guideline for registration of medical devices 2022 via AR dossier submission form for medical devices.
  2. The Authority will check for the format of the dossier submitted and communicate to the client for submission of product samples and payment of application fees if the dossier is as per the format via registered email address.
  3. The dossier will undergo Pre-Screening where the dossier will be evaluated for any discrepancies with regards to the format and incomplete document submission and such discrepancy will be communicated to the application via email. The applicant can submit the document using the Pre-screened missing documents submission link.
  4. The Authority will plan the dossier for Technical Evaluation after addressing the discrepancies observed during the Pre-screening phase by the applicants.
  5. The discrepancy observed during the Technical Evaluation will be communicated to the applicant via email and the applicant shall submit the missing documents using the Technical Evaluation missing documents submission link.
  6. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of Marketing Authorization of Traditional Medicines:

  1. Submit the application along with other documents via following links:
    1. Full dossier applications:
      1. Submit the duly filled
        application for Full registration of medicinal products
        along with the relevant documents as per
        Guideline for registration of medicinal products 2020
        in ACTD format prescribed by the authority via
        Full dossier submission link.
  2. The Authority will check for the format of the dossier submitted and communicate to the client for submission of product samples and payment of application fees if the dossier is as per the format via registered email address.
  3. The dossier submitted will be evaluated by the relevant sections during the monthly Dossier Evaluation Plan.
  4. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  5. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  6. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of Listing certificates of Supplements:

  1. Submit the duly filled
    Application for listing of Supplements
    along with the relevant documents as per
    Guideline for regulating Health Supplements
    and
    Guideline for regulating feed additives and supplements
    via
    Supplement dossier submission link.
  2. The dossier submitted will be evaluated by the relevant sections during the monthly Dossier Evaluation Plan.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  5. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of renewed Marketing Authorization of Pharmaceutical Products:

  1. Submit the duly filled
    Application for renewal of registration of medicinal products
    along with the relevant documents as per
    Guideline for registration of medicinal products 2020
    via
    Renewal dossier submission link.
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  5. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of renewed Marketing Authorization of Medical Devices:

  1. Submit the duly filled
    Application for renewal of medical device registration
    along with the relevant documents as per
    Guideline for registration of medical devices 2022
    via
    Renewal dossier submission form for medical devices.
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant shall submit the missing documents using the
    Missing documents submission link.
  5. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Issuance of renewed Marketing Authorization of Traditional medicines:

  1. Submit the duly filled
    Application for renewal of registration of medicinal products
    along with the relevant documents as per
    Guideline for registration of medicinal products 2020
    via
    Renewal dossier submission link.
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  5. The Marketing Authorization certificate shall be issued in hard copy after the payment of certificate fees.

Post Approval Variation (PAV) of Pharmaceutical Products:

  1. Submit the duly filled
    Application for Post Approval Variation of medicinal products
    along with the relevant documents as per
    Guideline for registration of medicinal products 2020
    via
    Post Approval Variation dossier submission link.
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  5. The PAV forward letter or new MA certificate shall be issued in hard copy.

Post Approval Variation (PAV) of Medical Devices:

  1. Submit the duly filled
    Application for Post Approval Variation of medical devices
    along with the relevant documents as per
    Guideline for registration of medical devices 2022
    via
    Post Approval Variation dossier submission link.

Post Approval Variation (PAV) of Traditional Medicines:

  1. Submit the duly filled
    Application for Post Approval Variation of medicinal products
    along with the relevant documents as per
    Guideline for registration of medicinal products 2020
    via
    Post Approval Variation dossier submission link.
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query, or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form.
  5. The PAV forward letter or new MA certificate shall be issued in hard copy.

Post Approval Variation (PAV) of Supplements:

  1. Submit the duly filled
    Application for Post Approval Variation of medicinal products
    along with the relevant documents as per
    Guideline for registration of medicinal products 2020
    via
    Post Approval Variation dossier submission link
  2. The dossier submitted will be evaluated by the relevant sections.
  3. The outcome of the dossier evaluation (Approved, Query or Rejected) will be communicated to the applicant via registered email with the Authority.
  4. The applicant will get 2 rounds of communication to address any discrepancies observed during the evaluation via
    Missing document submission form
  5. The PAV forward letter or new MA certificate shall be issued in hard copy.

Issuance of Import Authorization (IA) of Pharmaceutical Products:

  1. Log on to Government to Citizen (G2C) portal
  2. After logging in, click on the “Application for Import Authorization of Drug” from the list of services.
  3. Enter your Personal details and click next.
  4. Select the category of medicines, authorization purpose and registration status.
  5. Enter the details of the product and click “Next”.
  6. Upload the required documents and click “Submit”.
  7. You can view and download your Import Authorization from “Profile” in the Government to Citizen (G2C) Portal .

Issuance of Import Authorization (IA) of Medical Devices:

  1. Submit the duly filled Issuance of Import Authorization of Medical Devices along with the relevant documents as per Guideline for registration of medical devices 2022 via Post Approval Variation dossier submission link.

Post Approval Variation (PAV) of Traditional Medicines:

  1. Submit the duly filled Application for Authorization to import medical devices along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare import authorization certificates.
  3. The certificate shall be issued in hard copy.

Issuance of Import Authorization (IA) of Supplements:

  1. Submit the duly filled Application for Authorization to import medicinal products for sale and distribution along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare import authorization certificates.
  3. The certificate shall be issued in hard copy.

Issuance of Export Authorization (EA) of Pharmaceutical Products:

  1. Submit the duly filled Application for Export Authorization along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare export authorization certificates.
  3. The certificate shall be issued in hard copy.
  1. Submit the duly filled Application for Certificate of Pharmaceutical Products along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare certificates.
  3. The certificate shall be issued in hard copy.
  1. Submit the duly filled Application for Free Sale Certificate along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare certificates.
  3. The certificate shall be issued in hard copy.
  1. Submit the duly filled application along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and physically inspect the vaccines and biologicals.
  3. The Authority will issue a Lot Release certificate in hard copy.
  1. Submit the duly filled Application for advertisement clearance of medicinal products along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will evaluate the documents submitted and prepare certificates.
  3. The certificate shall be issued in hard copy.
  1. Submit the application form along with the relevant documents to the mpd@bfda.gov.bt via email.
  2. The concerned focal will write a letter to relevant agency for the clearance to dispose the medicinal product waste.
  3. If clearance is obtained, the Authority will communicate with the applicant on the date and place of disposal of listed medicinal product wastes.

Information

  1. List of Marketing Authorized pharmaceutical products
  2. Listed Supplements
  3. List of Marketing Authorized medical devices
  4. List of registered Competent Person
  5. List of authorised premises for sale and distribution of medicinal products
  6. List of authorised premises for manufacture of medicinal products;
  7. List of cancelled Marketing Authorization
  8. List of withdrawn Marketing Authorization
  9. List of recalled medicinal products
  10. List of Lot Released medicinal products
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